The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-05-24

Brief Summary

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The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.

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Detailed Description

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Conditions

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Fontan Circulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sildenafil crossover to placebo

Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2, placebo drug administered before the exercises.

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.

Placebo 2

Intervention Type DRUG

Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Placebo crossover to sidenafil

Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2 Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.

Sildenafil 2

Intervention Type DRUG

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).

Interventions

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Sildenafil

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.

Intervention Type DRUG

Placebo

Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.

Intervention Type DRUG

Sildenafil 2

oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).

Intervention Type DRUG

Placebo 2

Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Intervention Type DRUG

Other Intervention Names

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Viagra Ora-sweet and Ora-plus (1:1 ratio). Viagra Ora-sweet and Ora-plus (1:1 ratio).

Eligibility Criteria

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Inclusion Criteria

* Age 6-17 years
* Male or female
* Possess Fontan Circulation

Exclusion Criteria

* Severe heart failure (New York Heart Ass. functional class IV)
* Evidence of Fontan pathway obstruction
* History of exercise-induced severe arrhythmias
* Pregnancy (known or suspected)
* Orthopedic limitations that prevent ambulation on a treadmill
* Use of nitroglycerin
* Herbal medications

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes